At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed pancreatic adenocarcinoma
- ✓Completed 4-6 months of induction chemotherapy with FOLFIRINOX, NALIRIFOX, or gemcitabine/Abraxane
- ✓Locally advanced pancreatic cancer per NCCN Guidelines v1.2020 with defined vascular involvement criteria
- ✓Measurable disease per RECIST v1.1
- ✕Alternative or mixed histologies (squamous, neuroendocrine, acinar, colloid)
- ✕Completed induction chemotherapy less than 2 weeks or more than 8 weeks prior to enrollment
- ✕Residual toxicities >grade 1 from prior chemotherapy (except alopecia and neuropathy grade ≤2)
- ✕Currently receiving other investigational agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Study of M3814 (Peposertib) in Combination With Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma
In Brief
A Phase 1 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 5 other interventions for Locally Advanced Pancreatic Adenocarcinoma and Stage III Pancreatic Cancer AJCC v8. Currently recruiting, targeting 92 participants across 44 sites.
Detailed Summary
This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may be safe, tolerable and/or more effective than radiation therapy alone in treating patients with locally advanced pancreatic cancer.
Study Details
Timeline
Arms & Interventions
Patients in Phase I undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
Interventions
Undergo tissue collection
Undergo blood sample collection
Undergo CT
Undergo hypofractionated radiation therapy
Undergo MRI
Given PO
Given PO